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. 2020 Nov 4;2020(11):CD013004. doi: 10.1002/14651858.CD013004.pub2

Adamyan 2015a.

Study characteristics
Methods Study design: RCT
Unit of randomisation: No information
Total duration of study: 36 months
Run‐in period: No information
Intervention time: No information
Follow‐up: No information
Setting: Institute of Cardiology, Yerevan, Armenia
Participants Type of heart failure: CHF
N = 104 participants (ivabradine and BB: 51; SC: 53)
Mean age: 63.2 years (no SD reported)
Gender: No information
Severity of condition: No information
Inclusion criteria:
  • CHF

  • Preserved LV ejection fraction

  • NYHA class III


Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine max. 7.5 mg twice a day
Comparison: SC
Concomitant medications:
  • beta‐secretase inhibitors

  • BB

  • Diuretics


Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[Day 0, Month 12, 24, and 36]
  • Deceleration time of transmitral E waves

  • Deceleration time of transtricuspidal E waves

  • E/A ratio of transmitral flow

  • RV fractional area change

  • Tricuspidal annulus plane systolic excursion

  • Pulmonary artery ejection time

  • RA and LA fractional contribution

  • Functional index

  • Relation of pulmonary vein

  • Systolic and diastolic fraction

  • Systolic contribution

  • Difference between duration of reversal atrial flow

  • Late transmitral filling

  • NT‐pro‐BNP level

  • C‐reactive protein level


Conclusion:
  • "1. Decrease of NT‐pro‐BNP ≥ 50 %, reversal atrial flow to late transmitral filling ≥ 80%, C‐reactive protein level ≥ 40%, HR ≥ 25% and increase of Deceleration time of transmitral E waves (ECG) ≥ 80%, RA and LA functional index, pulmonary vein systolic contribution ≥ 50%, RA and LA fractional contribution, RV fractional area change, Deceleration time of transtricuspidal E waves and pulmonary artery ejection time at ≥ 25% identified pts with cardiac risk reduction."

  • "2. Ivabradine use associated with lower mortality and morbidity due to significant improvement of left ventricular, right ventricular, left atrial and right atrial functional parameters, neurohormonal and inflammation status and HR reduction."

Notes Funding for trial: No information
Notable conflicts of interest of authors: No information
Contact to authors/unpublished data: We contacted KG Adamyan and S Grigoryan via email on 22 November 2018 to ask for funding, country, number of centres, and missing data. The email to KG Adamyan failed, but S Grigoryan answered that she had forwarded the email to the correct email address. Nevertheless, we did not receive an answer.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to base judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to base judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding possible due to comparison with standard care.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to base judgement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to base judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to base judgement
Other bias Unclear risk Insufficient information to base judgement